Duluth, Minnesota:: Advanstar , 1996. Bright, clean, square, and tight. Mild EX-LIBRARY copy with NO library markings on the spine or covers. Stamped "WITHDRAWN" on the endpapers. Pages are fresh and crisp. Inner hinges are perfect. Pages are fresh and crisp. No underlining. No highlighting. No margin notes. Bound in the original glossy blue laminated boards, lettered in shiny silver on the spine. From the publisher: "DOCUMENTATION PRACTICES: A COMPLETE GUIDE TO DOCUMENT DEVELOPMENT AND MANAGEMENT FOR GMP AND ISO 9000 COMPLIANT INDUSTRIES includes everything you ever needed, or wanted, to know about documents and document management systems. It provides an accurate and meaningful understanding of manual document management requirements; features complete coverage of documents, documentation, document management, and document systems; and includes specific examples of Commitment Documents, Directive Documents, and Data Collection Documents. The information DOCUMENTATION PRACTICES provides will help the inexperienced reader understand the purpose of documents and documentation; will aide the experienced reader in designing new electronic documents, databases, and management systems; and will provide both with valuable insights when existing systems begin to fail." . First Printing of the First Edition. Hardcover. Near Fine EX-LIBRARY./No Jacket. 8vo. iv, 180pp.

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Bibliographic Details

Title: Documentation Practices : A Complete Guide to Document Development and Management for GMP and ISO 9000 Compliant Industries
Publisher: Advanstar, Duluth, Minnesota:
Publication Date: 1996
Language: English
ISBN 10: 0929870395
ISBN 13: 9780929870397
Binding: Hardcover
Edition: First Printing of the First Edition.
Condition: Near Fine EX-LIBRARY.
Dust Jacket Condition: No Jacket.

About this title

Synopsis

This book is written for the industry that develops, manufactures, and markets medical products for human and veterinary use. This industry is regulated by the FDA. The documents and the document management systems presented in this text, however, can be applied to any regulated industry, such as the EPA, USDA, or OSHA, or to any industry that develops or manufactures products for human use.

About the Author

Carol DeSain is an independent consultant with 22 years' experience in product development, manufacturing, and quality control, and specific expertise in the design and implementation of QA documentation systems.

Charmaine Vercimak Sutton is an independent consultant to medical product manufacturers, providing services in product development, clinical design and management, quality system development and implementation and regulatory compliance to meet FDA expectations.

Together, DeSain and Sutton provide GMP regulatory consulting for drug, device, and biologics manufacturers through their Tofte, Minnesota-based company, The Tamarack Group.

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